Temperature Mapping - A Comprehensive Guide

Welcome To Our Latest Edition of "Temperature Matters"

In this edition, I wanted to provide a comprehensive guide to some basic questions surrounding Temperature Mapping and Validation.

Whether you're a newcomer to the concept of temperature mapping or seeking to enhance your existing protocols, "Temperature Matters" is your go-to resource for all things related to temperature control in the critical environments of the Health & Life Science sector.

Firstly, a heartfelt thank you to our incredible sponsors, whose support allows us to share this knowledge on LinkedIn at no cost. Your dedication to our community is deeply appreciated.

Today's issue is brought to you by:

Managing a calibration program can be a daunting task. Are you struggling to keep track of your calibration schedule? Finding it challenging to ensure that equipment is calibrated on time, especially when faced with unexpected delays? The risk of using out-of-tolerance equipment can lead to significant compliance issues and impact product quality. Documentation, deviation management, and maintaining a robust calibration program are critical, yet complex, tasks that require meticulous attention to detail.

For a more in-depth understanding, I highly recommend Steve Lauver 's "Calibration Program Setup and Management Handbook." This guide offers step-by-step instructions on:

• Effective project planning
• Ensuring GMP compliance
• Optimizing resource management

From training and onboarding assets to asset numbering and classification, Steve's handbook covers all aspects of calibration management, providing you with the tools you need to maintain a robust, compliant, and sustainable program. Learn how to handle out-of-tolerance situations, overdue calibrations, and more with practical insights from an industry expert.

Get Your Copy

If you would like a FREE PDF copy of Ellab's handbook, please reach out to me directly, and I will be happy to forward it to you. Don't miss this opportunity to enhance your calibration management skills with expert guidance.

What is Temperature Mapping?

Temperature mapping, also known as thermal mapping, involves measuring and documenting temperatures at multiple predefined locations within a storage area over a specified period. This process ensures that Controlled Temperature Chambers (CTCs) can maintain predetermined temperature specifications, verifying the uniformity and stability of the temperature-controlled environment.

Why Perform Temperature Mapping?

Temperature mapping is essential for:

• Ensuring compliance with regulatory requirements from agencies like the FDA, EMA, and WHO.
• Validating the temperature uniformity and stability within storage environments.
• Identifying and mitigating any hot or cold spots that could compromise product integrity.
• Providing documented evidence that storage conditions meet necessary criteria for safe product storage.

When to Perform Temperature Mapping?

Temperature mapping should be conducted:

• During the initial qualification of a new storage area or equipment.
• After significant changes or modifications to the storage environment or equipment.
• Periodically as part of routine requalification to ensure ongoing compliance.
• In response to any deviation or significant environmental change affecting temperature stability.

How to Perform Temperature Mapping

Step 1: Review Relevant Guidelines and Regulations

Before starting the temperature mapping process, it is essential to understand the relevant guidelines and regulations that apply to your controlled temperature unit. This will ensure that the mapping process is conducted in compliance with regulations and that the results are meaningful.

Step 2: Validation Planning

Develop a comprehensive validation plan, which involves defining the scope and objectives of the mapping process, including worst-case scenarios. Determine the required resources and personnel, and identify any potential risks or challenges that may need to be addressed.

Step 3: Mapping Protocol Generation

Generate a detailed mapping protocol outlining the steps involved in conducting the temperature mapping process. This should include the placement of temperature mapping devices, the methods for collecting and analyzing temperature data, and any required quality control measures.

Step 4: Prepare the Temperature Mapping

Before conducting the temperature mapping, prepare the controlled temperature unit. This involves cleaning the unit, removing any stored materials, and ensuring that the unit is properly calibrated and functioning correctly. Always use appropriate Personal Protective Equipment (PPE) when handling and preparing the unit to ensure safety.

Step 5: Place Temperature Mapping Devices in the Unit

Place temperature data loggers or thermocouples at different locations throughout the unit according to a predetermined grid, including the top, bottom, and sides, as well as in the door and near any air vents. Stabilize the unit for a specified period before starting the mapping process.

Step 6: Execute the Temperature Mapping Process

With the temperature mapping devices in place, collect temperature data over a period of several hours or even days, depending on the specific requirements of your operation or equipment and storage area being assessed. A typical duration for Controlled Temperature Units (CTUs) is 24 hours to capture multiple temperature cycles, ensuring consistent temperature maintenance.

Step 7: Analyze and Interpret the Temperature Mapping Data

Once the temperature mapping process is complete, analyze and interpret the data collected. This involves generating reports and graphs that show the temperature distribution throughout the unit, as well as identifying any areas that are not meeting the required temperature range and determining the root causes.

Step 8: Implement Corrective Actions

Based on the results of the temperature mapping, it may be necessary to implement corrective actions to ensure that the unit is operating correctly. This may involve making changes to the temperature control system, adding or repositioning temperature mapping devices, or other actions to improve the temperature stability of the unit.

Step 9: Summary Report Preparation

Prepare a summary report documenting the results of the temperature mapping process, including any corrective actions taken. This report should be comprehensive, clearly documenting the methodology used, the results of the mapping process, and any conclusions drawn from the data. Ensure that this report is reviewed and approved by qualified personnel.

FREE step-by-step guide: ellab-a-9-step-guide-for-temperature-mapping-an-ultra-low-freezer.pdf

What Types of Equipment Require Temperature Mapping?

Temperature mapping is critical for various types of equipment and environments, including:

• Refrigerators and freezers (standard, ultra-low, and cryogenic)
• Warehouses and distribution centers
• Stability chambers and environmental test chambers
• Incubators and ovens
• Cold rooms and clean rooms
• Transport vehicles used for cold chain logistics

What Types of Validation Equipment are Used for Temperature Mapping?

Various types of validation equipment are utilized, including:

• Data Loggers: Devices that continuously record temperature data over time, such as Ellab - Validation & Monitoring Solutions data loggers.
• Wired Validators: Highly accurate validation systems for critical temperature mapping studies, such as the E-VAL Pro Plus.
• Thermocouples and RTDs: Sensors used for precise temperature measurements, often connected to data loggers.
• Calibration Tools: Instruments ensuring all sensors and loggers are calibrated to NIST traceable standards.

Temperature Mapping Considerations

Consider the following when performing temperature mapping:

• Sensor Placement: Ensure adequate coverage of the environment to capture temperature variations accurately.
• Duration: Monitor for a sufficient period to capture any temperature fluctuations due to operational activities.
• Calibration: Use calibrated equipment to ensure accurate and reliable data.
• Environmental Conditions: Consider external factors like ambient temperature and humidity that may impact mapping results.
• Data Integrity: Maintain robust procedures for data collection, storage, and analysis to ensure integrity and traceability.

What to Look for When Selecting a Temperature Mapping Contractor

Consider these factors when selecting a contractor:

• Experience and Expertise: Look for a contractor with a proven track record in temperature mapping and validation services.
• Compliance: Ensure the contractor follows industry guidelines and regulatory requirements.
• Equipment Quality: Verify that the contractor uses high-quality, calibrated equipment.
• Reporting and Documentation: Assess the quality and comprehensiveness of the contractor’s reporting and documentation processes.
• Support and Service: Evaluate the level of support and after-service the contractor offers, including troubleshooting and corrective actions.

What A Great Validation and Temperature Mapping Company Should Offer

A great validation and temperature mapping company should be able to provide comprehensive temperature mapping services and solutions, including:

• Temperature Mapping Services: End-to-end temperature mapping studies for various controlled environments.
• Validation Solutions: Equipment and expertise for Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) processes.
• Monitoring Solutions: Real-time monitoring systems to ensure continuous compliance and environmental stability.
• Calibration and Metrology Services: Calibration of all sensors and loggers to NIST traceable standards.
• GxP Services: Expertise in Good Manufacturing Practice (GMP) compliance to ensure regulatory adherence and product integrity.

A great validation and temperature mapping company's commitment to quality, compliance, and continuous improvement will drives efficiency and excellence in validation and temperature mapping, empowering the health and life sciences industry with innovative, practical solutions. Who is your go-to service provider?

Exclusive Content:

Qualification Protocol Guidance

A robust qualification protocol and accurate temperature mapping are vital for ensuring the integrity, safety, and efficacy of your products. They help identify potential risks, maintain compliance with regulatory standards, and ultimately protect end-users. By thoroughly validating your processes and equipment, you prevent costly errors and ensure consistent product quality.

Essential Components of a Qualification Protocol

A robust protocol should include:

• Purpose: Define the objectives of the qualification.
• Scope: Specify the range and limits of the study.
• Equipment Description: Detailed information on the equipment.
• Responsibilities: Clearly assigned roles and tasks.
• Test Method: Detailed approach for conducting qualification.
• IQ/OQ/PQ: Comprehensive test scripts (listed below).
• Acceptance Criteria: Benchmarks for successful qualification.
• Summary Report: Consolidation of findings and results.
• Post-Execution Approval: Final sign-off after successful qualification.

Expert Guidance

The ISPE Good Practice Guide provides invaluable insights into commissioning, qualification, temperature mapping, maintenance, and periodic reviews. It also offers examples and sample templates to streamline your process.

Key Test Scripts for Temperature Mapping Protocol

Installation Qualification (IQ):

• Standard Operating Procedures
• Equipment and Utility Installation Verification
• Documentation and Drawings Verification
• Calibration Status of Critical Instruments
• Test Instrument Calibration Information

Operational Qualification (OQ):

• Operational Controls and Setpoint Verification
• Alarm Verification
• Empty Chamber Temperature Mapping Study
• Additional Tests: Open Door Verification, Power Loss Temperature Test

Performance Qualification (PQ):

• Loaded Chamber Temperature Mapping Study

Pro Tips for Mapping Locations

When determining mapping locations, consider:

• Number of Probes: Ensure adequate coverage.
• Distance Between Probes: Maintain appropriate spacing.
• Usable Space: Maximize coverage of the storage area.
• Air Flow Path: Account for direct airflow patterns.

Quote: "Everyone knows what needs to be done, but they’re not always sure how to get there. We know how to get there because that’s what we do, over and over again. We employ proven methods to guide our clients towards better solutions." - Nathan Roman ??

Stay Tuned:

Stay tuned for more insights and reflections in our upcoming editions. As we continue to navigate the complexities and advancements in our field, we'll share experiences, challenges, and successes that connect us all. Your engagement and feedback are not just welcomed; they are essential in shaping our journey together. So, let's keep the conversation going, learning from each other and striving towards excellence in everything we do. Thank you for being a part of this community.

Ready to Elevate Your Temperature Mapping Expertise?

Whenever you're ready, there are 3 ways we can assist you in mastering temperature mapping studies:

?? Explore Expert Insights: Subscribe and discover actionable tips, industry trends, and expert knowledge to enhance your skills.

?? Join the Pharma Temp Mapping LinkedIn Group: Gain access to in-depth content, practical workshops, and a community of fellow temperature mapping enthusiasts. Join here: Pharma Temp Mapping

?? Book a Call with Me: Schedule a personalized 30-minute call designed to help you take the next step in your temperature mapping journey. Receive tailored advice and insights to overcome specific challenges and enhance your expertise. Book A Call

Choose your path to temperature mapping excellence, and let's embark on this journey together. We're committed to your success in temperature mapping and look forward to journeying together.

I hope you're able to find value in this article. If you did, please subscribe to this newsletter and follow me on LinkedIn.

Warm regards,

Nathan Roman ??

P.S. Promote Yourself!

?? Get Featured: Put your brand in front of our engaged audience of industry experts and decision-makers. Secure your spot in our newsletter, and connect with 12,000+ followers who value expertise and innovation. Send me a Direct Message.

#TemperatureMapping #Validation